MMIT Reality Check on Urothelial/Bladder Cancer (2Q2023)

Payer Coverage:

A review of market access for urothelial/bladder cancer shows that under the pharmacy benefit, about 39% of the lives under commercial formularies are covered with utilization management restrictions. Around 60% of the lives under Medicare formularies are not covered for at least one of the drugs.

Under the medical benefit, about 63% of the lives under commercial policies are covered with utilization management restrictions. Almost 68% of the lives under Medicare policies have access to at least one of the drugs without utilization management restrictions.

For about 98% of the covered lives, payer pharmacy benefit formularies do not require step therapy (ST). Of the lives that require ST, all require a single step. Around 71% of payer-controlled pharmacy benefit covered lives require prior authorization.

Trends:

FDA Gave Accelerated Approval to Keytruda/Padcev Combo

In April 2023, the FDA gave accelerated approval to the combination therapy of Merck & Co., Inc.’s Keytruda (pembrolizumab) and Astellas Pharma Inc. and Seagen Inc.’s Padcev (enfortumab vedotin-ejfv) or Padcev with Keytruda for the first-line treatment of adults with locally advanced or metastatic urothelial cancer who are not eligible to receive cisplatin-containing chemotherapy. It is the first combination of a programmed death receptor-1 (PD-1) inhibitor and an antibody-drug conjugate as a treatment option in this patient population. The FDA first approved Padcev, a Nectin-4-directed antibody and microtubule inhibitor conjugate, on Dec. 18, 2019, and first approved Keytruda on Sept. 4, 2014. Dosing for this combination use is 1.25 mg/kg of Padcev via a 30-minute infusion on days one and eight of a 21-day cycle and 200 mg of Keytruda every three weeks via a 30-minute intravenous infusion or 400 mg every six weeks. Drugs.com lists the price of a 30 mg lyophilized powder in a single-dose vial of Padcev as more than $4,196. Keytruda is priced at $10,683.52 for every-three-weeks dosing and $21,367.04 when dosed every six weeks.

Bladder Cancer Gene Therapy Adstiladrin Offers New Option in Slim Category

In late 2022, the FDA approved the first gene therapy for bladder cancer, Ferring Pharmaceuticals’ Adstiladrin (nadofaragene firadenovec-vncg). Almost three-quarters of oncologists surveyed by Zitter Insights expressed at least moderate interest in the agent, and payers said they expect to manage the drug to label. While the drug gives another treatment alternative to a much-needed area, it likely will continue to put financial pressure on payers, industry experts tell AIS Health, a division of MMIT.

FDA Approves Adstiladrin

In December 2022, the FDA approved Ferring Pharmaceuticals’ Adstiladrin (nadofaragene firadenovec-vncg) for the treatment of adults with high-risk, Bacillus Calmette-Guerin (BCG)-unresponsive non-muscle invasive bladder cancer with carcinoma in situ (CIS) with or without papillary tumors. The agency gave the novel adenovirus vector-based gene therapy priority review, breakthrough therapy and fast track designations. Dosing is once every three months into the bladder via a urinary catheter. The company said it expects the therapy to be available in the second half of 2023.

Key Findings:

Market Events Drive Changes

In April 2023, the FDA gave accelerated approval to the combination therapy of Merck & Co. Inc.’s Keytruda (pembrolizumab) with Astellas Pharma Inc. and Seagen Inc.’s Padcev (enfortumab vedotin-ejfv) or Padcev with Keytruda for the first-line treatment of adults with locally advanced or metastatic urothelial cancer who are not eligible to receive cisplatin-containing chemotherapy. In December 2022, the agency approved Ferring Pharmaceuticals’ Adstiladrin (nadofaragene firadenovec-vncg) for the treatment of adults with high-risk, Bacillus Calmette-Guerin (BCG)-unresponsive non-muscle invasive bladder cancer with carcinoma in situ (CIS) with or without papillary tumors. In August 2021, the FDA expanded the label of Bristol-Myers Squibb Co.’s Opdivo (nivolumab) to include the adjuvant treatment of people with urothelial carcinoma who are at high risk of recurrence after undergoing radical resection. It is the first therapy that the agency approved for this use. Several new drugs for bladder cancer of all stages have been approved in recent years, and more treatments are on the horizon.

Competitive Market Landscape

Several anti-PD-L1 monoclonal antibodies are currently FDA approved for urothelial cancer. There is only one Nectin-4-directed antibody and microtubule inhibitor conjugate and one gel form of mitomycin. Many payers have policies written to manage the use of these agents in the treatment of urothelial cancer and their place in the treatment pathway.

Pharmacy, Medical Benefit Implications

Balversa (erdafitinib), a tablet from Janssen Biotech, Inc., a Johnson & Johnson unit, is processed through the pharmacy benefit, while the rest of the products currently approved for urothelial cancer are primarily processed through the medical benefit since they are required to be administered by a physician or authorized health care provider. In general, for provider-administered products, there are policies covering an entire class for an oncology indication when two or more products in a class carry an FDA approval.

Key Players in Market:

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